BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD BRL LAG SCRW 12.5X95MM

    MDR report key: 7211744 · Received January 23, 2018

    Report

    Report Number
    3002806535-2018-00154
    Event Type
    Malfunction
    Date Received
    January 23, 2018
    Date of Event
    January 2, 2018
    Report Date
    August 7, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT RELATING TO THE REPORTED EVENT HAS BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION. VISUAL CHECKS: ON RECEIVING THE ¿HIPLOC PLATE¿ AND ¿HIPLOC LAG SCREW¿ A VISUAL CHECK WAS PERFORMED WITH THE FOLLOWING OBSERVATIONS FOUND:- HIPLOC PLATE ¿ VARIOUS SCRATCHES AND MARKING FROM HANDLING AND ATTEMPTED IMPLANTATION. ¿ ETCHING IS CLEAR. HIPLOC LAG SCREW ¿ VARIOUS SCRATCHES AND MARKING FROM HANDLING AND ATTEMPTED IMPLANTATION. ¿ ETCHING IS CLEAR. DOCUMENT REVIEW: A REVIEW OF THE MANUFACTURING HISTORY RECORDS FOR THE HIPLOC PLATE FROM THIS EVENT HAS NOT REPORTED ANY ABNORMALITIES OR DEVIATIONS. COMPLAINTS 13 COMPLAINTS HAVE BEEN RECORDED FOR A SIMILAR ISSUE. . THE RETURNED HIPLOC PLATES HAVE BEEN CONFIRMED AS NON-CONFORMING. THE INTERNAL BARREL ON THE HIPLOC PLATE HAS BEEN CONFIRMED AS UNDERSIZE THROUGH DIMENSIONAL CHECKS. THE HIPLOC LAG SCREWS IN ALL RETURNED PRODUCT HAVE BEEN CONFIRMED AS CONFORMING TO PRE-DEFINED SPECIFICATION WHEN MANUFACTURED, AND REQUIRE NO FURTHER ACTION TO BE TAKEN. A SUPPLIER CORRECTIVE ACTION REPORT, SCAR- 01951, HAS BEEN RAISED ON SANATMETAL TO INVESTIGATE THEIR MANUFACTURING PROCESSES IN RELATION TO THE NON-CONFORMANCE. THE RISK ASSESSMENT RESIDUAL SCORE HAS INCREASED AND WILL BE CONSIDERED BY THE PRODUCT ENGINE MANAGEMENT TEAM AS PART OF A HEALTH HAZARD EVALUATION HHE2018-00210.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: STD BRL 4-HOLE PLATE 135 DEG, ITEM 2110-135-004 , LOT 6097521. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2018- 00153.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE LAG SCREW WAS TESTED OUTSIDE THE PATIENT, THE SCREW GOT STOCK IN THE PLATE. ANOTHER LAG SCREW AND PLATE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55331 STD BRL LAG SCRW 12.5X95MM HRS BIOMET UK LTD. N/A 2016110318

    Patients

    Seq Age Sex Outcome Treatment
    1